Spectrum Requirements for Advanced Medical Technologies, 52472-52478 [2010-21011]

Agencies

• FEDERAL COMMUNICATIONS COMMISSION

[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Rules and Regulations]
[Pages 52472-52478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21011]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Part 95

[ET Docket No. 06-135; FCC 10-128]


Spectrum Requirements for Advanced Medical Technologies

AGENCY: Federal Communications Commission.

ACTION: Final rule.

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SUMMARY: This document addresses a petition for reconsideration 
(petition) filed by Medtronic, Inc. (Medtronic) regarding rules for the 
Medical Device Radiocommunication (MedRadio) service. The Commission 
grants reconsideration to the extent of amending the MedRadio rules to 
permit the submission of average power transmitter measurements, and 
making editorial corrections or clarifications to several provisions 
concerning the frequency monitoring criteria and permissible 
communications for ``listen-before-talk'' (LBT) and non-LBT devices. 
The Commission denies reconsideration in all other respects and 
otherwise affirms certain provisions of the MedRadio rules questioned 
by Medtronic.

DATES: Effective September 27, 2010.

FOR FURTHER INFORMATION CONTACT: Mark Settle, (202) 418-1569 or Gary 
Thayer, Policy and Rules Division, Office of Engineering and 
Technology, (202) 418-2290, Mark.Settle@fcc.gov or Gary.Thayer@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's 
Memorandum Opinion and Order, ET Docket No. 06-135, adopted July 15, 
2010, and released July 26, 2010. The full text of this document is 
available on the Commission's Internet site at https://www.fcc.gov. It 
is also available for inspection and copying during regular business 
hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., 
Washington, DC 20554. The full text of this document also may be 
purchased from the Commission's duplication contractor, Best Copy and 
Printing Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, 
DC 20554; telephone (202) 488-5300; fax (202) 488-5563; e-mail 
FCC@BCPIWEB.COM.

Summary of the Memorandum Opinion and Order

    1. The Commission addresses a petition for reconsideration 
(petition) filed by Medtronic, Inc. (Medtronic) regarding rules for the 
Medical Device Radio-communication (MedRadio) service. The Commission 
granted reconsideration to the extent of amending the MedRadio rules to 
permit the submission of average power transmitter measurements, and 
making editorial corrections or clarifications to several provisions 
concerning the frequency monitoring criteria and permissible 
communications for ``listen-before-talk'' (LBT) and non-LBT devices. 
The Commission denied reconsideration in all other respects and 
otherwise affirmed certain provisions of the MedRadio rules questioned 
by Medtronic.
    2. The Commission established the MedRadio service under part 95 of 
the rules by Report and Order (MedRadio Order), see 74 FR 22696, May 
14, 2009. Altogether, the MedRadio service provides a total of five 
megahertz of contiguous spectrum for advanced wireless medical 
radiocommunication devices serving a diverse range of diagnostic and 
therapeutic purposes in humans. In the MedRadio Order, the Commission 
also adopted service and technical rules governing the operation of 
medical radiocommunication devices used in the MedRadio service. 
Building upon the former Medical Implant Communications Service 
(MICS)--which limited operation to implanted medical devices--the more 
flexible MedRadio rules accommodate body-worn as well as implanted 
medical devices, including those using either LBT or non-LBT spectrum 
access methods. The MedRadio service incorporates the MICS ``core'' 
band at 402-405 MHz--which continues to be limited to implanted 
devices--and also includes two megahertz of newly designated spectrum 
in the adjacent ``wing'' bands at 401-402 MHz and 405-406 MHz--in which 
both body-worn and implanted devices are permitted. The MedRadio 
service continues to incorporate many of the licensing and technical 
requirements that applied to the legacy MICS.
    3. Medtronic requests that the new MedRadio rules be amended to 
permit transmitter power measurements to be made using average power 
instrumentation techniques that were formerly allowed under the MICS 
rules. The former MICS rules stated that compliance with the maximum 
transmitter power limits shall be based upon measurements using a peak 
detector function or, alternatively, the instrumentation techniques set 
forth in a particular American National Standards Institute (ANSI) 
standard referenced in the rule. That standard has been modified by 
ANSI since adoption of the MICS rules in 1999 and no longer includes 
the specific average power instrumentation techniques cited by 
Medtronic. As adopted in the MedRadio Order, the new rules set forth a 
compliance requirement in terms of a ``Commission-approved peak power 
technique.'' Medtronic argues that the Commission did not propose to 
delete these provisions of the MICS rules in the Notice of Proposed 
Rulemaking (MedRadio NPRM) that preceded the adoption of the MedRadio 
rules, see 71 FR 43682, August 2, 2006. Medtronic further asserts that 
the peak power requirement as set forth in the rule adopted in the 
MedRadio Order would, in effect, prohibit the use of average power 
instrumentation techniques that were acceptable within the scope of the 
former MICS rule. It contends that the inability to rely upon these 
average power techniques for compliance would require MedRadio devices 
to reduce power, and that this, in turn, would be detrimental to the 
reliable operation of existing equipment and adversely affect the 
development of new generation devices. To remedy this concern, 
Medtronic recommends that the Commission reinstate the former MICS rule 
provision or, in the alternative, restore the intent of the prior rule 
by substituting text that would permit the use of average power 
measurement techniques. St. Jude Medical agrees with Medtronic, stating 
that the effect of the peak power measurement rule will be to sharply 
reduce the range available to some systems. Biotronik opposes 
Medtronic's request, stating that the peak power approach adopted in 
the MedRadio Order is a more appropriate technique for MedRadio 
transmitters because average power measurements would allow higher 
power devices in the band and, thus, increase the potential for 
interference in the band.
    4. As a threshold matter, the Commission addresses Medtronic's 
suggestion that it failed to provide sufficient notice for modifying 
the power measurement provisions. While the Commission acknowledges 
that the MedRadio NPRM did not explicitly request comment on whether 
the power measurement provisions should be modified, changes to these 
measurement provisions are a logical outgrowth of issues in the 
MedRadio NPRM that we did present for comment. More specifically, the 
Commission

[[Page 52473]]

specifically invited comment on power and duty cycle thresholds for 
MedRadio devices and emphasized that its proposed rules were intended 
to allow flexibility in spectrum usage for MedRadio devices. Thus, it 
would be reasonable for interested parties to anticipate that the 
Commission would also adopt rules for determining whether such devices 
comply with those rules, including power measurement methods. In 
addition, in the MedRadio NPRM, the Commission sought comment on 
``whether the various current MICS rules would continue to be 
appropriate for operations under the new allocation.'' Parties should 
have anticipated that the Commission could conclude that a reference to 
an outdated ANSI standard would not ``continue to be appropriate for 
operations under the new allocation.'' Accordingly, the Commission 
concluded that the power measurement rule revisions adopted in the 
MedRadio Order are logical outgrowths of the MedRadio NPRM, and 
therefore, that the Commission provided sufficient APA notice for these 
revisions.
    5. The Commission notes that it was not its intent to change the 
underlying frame of reference for measuring allowable transmit power, 
which is a maximum EIRP over a specified bandwidth, but recognizes that 
removing the reference to the obsolete ANSI standard (in combination 
with the reference to the alternative power measurement technique using 
a peak detector function) contributed to the uncertainty over whether a 
previously acceptable average power measurement technique would 
continue to be allowed. Accordingly, the Commission is amending Sec.  
95.628(g)(3) of the MedRadio rules to restore the approach in the 
former MICS rule which specified a peak detector function as one 
measurement technique for demonstrating compliance with transmitter 
power limits. In substitution for the obsolete ANSI standard of the 
former MICS rule, the Commission is also adding a provision that 
expands the available options for demonstrating compliance by stating 
that measurement procedures found acceptable to the Commission in 
accordance with 47 CFR 2.947 may also be used. In addition, the Office 
of Engineering and Technology (OET) Laboratory Division has published 
information in its Knowledge Data Base (KDB) concerning acceptable 
average power measurement procedures under this provision. The 
Commission believes that this approach satisfies the substance of 
Medtronic's request that the MedRadio rules be modified to permit the 
average power instrumentation techniques formerly acceptable under the 
MICS rules.
    6. This approach also provides greater flexibility than the former 
MICS rule, which, in part, relied upon the ANSI standards, because it 
avoids inadvertent rule obsolescence as industry standards are modified 
or new measurement techniques are developed. Under its Part 2 rules, 
the Commission can provide specific guidance as to the measurement 
approaches that are acceptable through the issuance of bulletins or 
reports--such as recently has been provided in the OET KDB noted in the 
Memorandum Opinion and Order--and without the need to correct outdated 
references in the underlying rules through time-consuming, formal 
proceedings. Moreover, in the event the Commission has not provided 
guidance on a particular matter through bulletins or reports, the rules 
also allow parties to provide a detailed description of the measurement 
procedures actually used for the Commission's consideration in 
determining compliance with its technical rules.
    7. Non-LBT devices. Regarding the frequency monitoring criteria for 
non-LBT devices, Medtronic correctly points out in its petition that 
the text of the MedRadio Order limits the number of transmissions per 
hour for non-LBT devices, but that these restrictions were omitted from 
the appropriate paragraph of Sec.  95.628 (``MedRadio Transmitters'') 
as adopted. Medtronic requests that these limitations be added to 
paragraphs (b)(2) through (b)(4)--the paragraphs which also specify the 
duty cycle limits for non-LBT devices. The Commission concurs. The text 
of the MedRadio Order explicitly states that maximum number of 
communication sessions per hour for non-LBT devices shall be ten (10) 
per hour for devices operating with 0.01% duty cycle within the 402-405 
MHz core band, and one hundred (100) per hour for devices operating 
with 0.1% duty cycle in the wing bands. The omission of these 
provisions from the adopted rule was an editorial oversight. Therefore, 
the Commission amends Sec.  95.628, paragraphs (b)(2) through (b)(4) to 
add these limits to conform to the literal intent of the MedRadio 
Order.
    8. Medtronic also states that Sec.  95.1209(d) (``Permissible 
Communications'') as adopted appears to contain unnecessary language 
that could be interpreted as allowing non-LBT devices to operate 
without the communication of data. Medtronic argues that such non-data 
transmissions are inappropriate for non-LBT devices which do not employ 
frequency monitoring pursuant to Sec.  95.628(b). Biotronik also 
supports this request for the same reasons. In the same subsection, 
Medtronic points out a clerical error in the text which mismatches the 
cross-references to limits set forth in Sec.  95.628, subsections 
(b)(3) through (b)(4), with respect to non-LBT devices operating with 
0.1% or 0.01% duty cycles.
    9. The Commission agrees that the rules should be changed as 
Medtronic requests. The reference to non-LBT devices operating 
``without the communication of data'' in Sec.  95.1209(d) as adopted in 
the MedRadio Order was inadvertently carried over from the legacy MICS 
rule provisions. Historically, MICS devices were limited to LBT 
operation. Further, as Medtronic correctly points out, some small 
amount of non-data transmission is necessary to perform the LBT 
frequency monitoring protocol prescribed in the rules. By comparison, 
the new MedRadio rules encompass the operation of non-LBT as well as 
LBT devices. Since non-LBT devices, by definition, do not employ 
frequency monitoring prior to transmitting data, it would be spectrally 
inefficient and contrary to the intent of the MedRadio Order for such 
devices to operate without the transmission of data.
    10. Thus, the Commission amends Sec.  95.1209(d) to remove the 
reference to non-LBT devices operating without the communication of 
data. In addition, the Commission rectifies the cross references to the 
appropriate duty cycle and maximum transmission limits set forth in 
Sec.  95.628--namely, that non-LBT devices operating pursuant to Sec.  
95.628, subsections (b)(2) and (b)(3), with 0.1% duty cycle may 
transmit for no more than 3.6 seconds per hour; and that non-LBT 
devices operating pursuant to Sec.  95.628, subsection (b)(4), with 
0.01% duty cycle may transmit for no more than 360 milliseconds per 
hour.
    11. LBT Devices. The frequency monitoring rules for LBT devices 
require that the devices monitor channel(s) that they intend to occupy 
but not initiate a communications session unless certain access 
criteria are met. These criteria include a threshold power level; the 
LBT device may use a channel if no signal above the threshold power 
level is detected on that channel or, if no monitored channel meets 
this requirement, the channel with the lowest ambient power level (the 
``least-interfered-channel'' or ``LIC''). Medtronic urges the 
Commission to amend the MedRadio rules to clarify that single-channel 
LBT devices operating under the LIC provisions of Sec.  95.628(a)(4) 
must wait to transmit until the monitoring

[[Page 52474]]

threshold power level specified in Sec.  95.628(a)(1) is not exceeded 
on the device's single channel of operation. Medtronic states its 
belief that this interpretation was intended by the MedRadio Order, but 
nevertheless seeks clarification to resolve any ambiguity. More 
specifically, Medtronic observes that the rule's language tacitly 
envisions MedRadio transmitters capable of operating on multiple 
channels--such that the availability of an alternate channel is a 
meaningful option. In this light, Medtronic argues that a strained 
reading as applied to single channel LBT devices--which, by definition, 
cannot operate on an alternate channel--could lead to the 
interpretation that such devices may transmit at will regardless of 
whether the LBT monitoring threshold had been met. Such an 
interpretation, Medtronic argues, would essentially write the LBT 
requirement out of the rule for single channel devices. Biotronik 
supports this request.
    12. The Commission agrees that the rules should be amended to state 
this clarification. The intended interpretation is that the LBT 
threshold requirement applies to both multi- and single-channel 
devices. It also concurs with Medtronic's assertion that a contrary 
interpretation would obviate the LBT requirement for single channel 
devices, thereby undermining our goal of fostering equitable band 
sharing by all LBT devices. Further, while the Commission believes that 
the contrary characterization that Medtronic cautions against would be 
a strained reading of the rule, it nevertheless wishes to prevent any 
misunderstanding. Accordingly, as applied to single channel LBT 
devices, the Commission clarifies that Sec.  95.628(a)(4) shall be 
interpreted to require that such devices must wait to transmit until 
the monitoring threshold on the single channel of operation is not 
exceeded. The Commission is adding text to Sec.  95.628(a)(4) 
reflecting this clarification.
    13. Medtronic also requested that the Commission clarify that a 
MedRadio device operating under the LIC provisions of Sec.  
95.628(a)(4) must monitor--and be capable of operating on--a specified 
minimum number of channels (e.g., 9 for the core band, and 18 for the 
wing bands). With support from Biotronik, Medtronic argues that such a 
requirement would ensure that devices using the least interfered 
channel provisions of Sec.  95.628(a)(4) operate on the remaining 
alternate channels that have the lowest ambient power levels, thereby 
fostering more efficient band sharing while minimizing mutual 
interference.
    14. The Commission declines to modify the rule and affirms the rule 
as adopted. As an initial matter, the Commission notes that no such 
requirement was contained in the former MICS rules, and that no mention 
of adopting such a requirement was made in the MedRadio NPRM. 
Furthermore, and on the merits, the Commission also finds that 
establishing such a requirement on reconsideration would be 
inconsistent with our general desire, as articulated in the MedRadio 
Order, to adopt rules generally in conformance with the MICS while 
providing greater flexibility. The Commission believes that it is 
desirable to give manufacturers and the marketplace ample opportunity 
to determine the device channeling capabilities that are most useful 
for a particular application. Thus far, no problems have been reported 
to us resulting from this flexibility, and Medtronic presents no facts 
that would cause us to reconsider this decision.
    15. Finally, Medtronic asks that the Commission reconsider the 
decision in the MedRadio Order to reject Medtronic's request--which it 
first raised in a January 10, 2008 ex parte submission--to modify the 
LBT monitoring threshold set forth in Sec.  95.628(a)(3) for devices 
that transmit with less than the maximum allowed power. The Commission 
declined to modify the LBT monitoring threshold because the issue was 
not raised in the MedRadio NPRM and thus there was little substantive 
basis on the record for modifying the rule. At the time of its 
submission, Medtronic asked that LBT threshold specified in the MICS 
rules be modified to increase the LBT threshold by 1 db for every 1 dB 
that the EIRP of the monitoring systems transmitter is below the 
maximum permitted level of 25 microwatts EIRP for both body-worn and 
implanted MedRadio devices across the entire 401-406 MHz MedRadio band. 
Medtronic further stated that this modification would harmonize with 
recently adopted ETSI standards for low-power medical device data 
communications in other countries. Medtronic merely reiterates these 
claims in its petition, and suggests that the requested modification 
would only affect devices with lower interference potential. More 
recently, in subsequent ex parte submissions, Medtronic characterizes 
its request as being limited to body-worn devices when acting as 
programmer/control transmitters, and that it is not seeking a change to 
the LBT threshold for standalone programmer/control transmitters.
    16. Upon reconsideration, the Commission affirms the finding in the 
MedRadio Order that insufficient notice was provided in the MedRadio 
NPRM to support modifying the LBT threshold as requested. The mere fact 
that Medtronic raised the subject of a modified LBT threshold for the 
first time in an ex parte submission does not cure this basic lack of 
sufficient notice in the MedRadio NPRM itself.
    17. The Commission also affirms the finding in the MedRadio Order 
that there was insufficient substantive discussion in the comment 
record to support such a modification. The Commission believes that 
modifying the monitoring threshold as suggested by Medtronic raises 
several issues that require further analysis. For example, Medtronic 
states that this modification would harmonize with recently adopted 
ETSI standards for low-power medical device data communications in 
other countries, but seeks to limit its application to only body-worn 
devices when acting as programmer/control transmitters across the 
entire 401-406 MHz MedRadio band. Although the ETSI standard cited by 
Medtronic does include the substance of the modified LBT threshold, 
this standard only covers the 401-402 MHz and 405-406 MHz wing bands, 
and also applies to both implanted and body-worn devices when used to 
select the frequency of operation. In addition, the Commission has to 
consider the impact of a higher monitoring threshold on primary METAIDS 
users in these frequency bands which might increase the likelihood of a 
medical device seeking to operate on a channel being used by a METAIDS 
device. Medtronic seeks to minimize these concerns by asserting that 
LBT medical devices would suffer no more interference from METAIDS 
devices than non-LBT devices, but it offers no analysis to support this 
assertion. These concerns lead us to conclude that insufficient 
substantive record has been developed to act on Medtronic's request at 
this time. The first step to develop such a record, to the extent it 
wishes to further proceed on this question, is for Medtronic to file a 
petition for rulemaking with the Commission.
    18. Human Torso Simulator and Testing Technique. The transmitters 
used for medical implant and body-worn devices authorized under the 
MedRadio rules are required to be tested to determine compliance with 
radiated emissions and EIRP limits. Medtronic requests that the rules 
be modified to reinstate a provision requiring use of a particular 
human torso simulator test technique for implanted medical

[[Page 52475]]

devices that was set forth in former Sec.  95.639(f)(2)(i) of the MICS 
rules. Medtronic states that the corresponding new MedRadio provision, 
Sec.  95.628(g)(3)(i), which more broadly requires a ``Commission-
approved human body simulator and test technique,'' fails to provide 
sufficient guidance about what type of measurement data is required. 
Medtronic also claims that no changes to the test technique were 
proposed in the MedRadio NPRM. Medtronic further argues that the former 
MICS provision reduces possible confusion by providing, in effect, a 
safe harbor for compliance purposes. Biotronik supports this request 
for the same reasons.
    19. The Commission denies this request and affirms Sec.  
95.628(g)(3)(i) of the new MedRadio rules as adopted. The new rule is 
more permissive than the former MICS rule and provides greater 
flexibility in testing devices by expanding, rather than limiting, 
available measurement compliance options. As the Commission observed 
regarding procedures for measuring average power, Sec.  2.947 of the 
rules allows the Commission to provide specific guidance as to the 
measurement approaches that would be acceptable in a more responsive 
and timely manner through the issuance of bulletins or reports and 
without the need to correct outdated references in the underlying rules 
through time-consuming, formal proceedings. Moreover, in the event the 
Commission has not provided guidance through bulletins or reports, the 
rules also allow parties to provide a detailed description of the 
measurement procedures actually used for the Commission's consideration 
in determining compliance with its technical rules. This approach also 
forestalls inadvertent rule obsolescence as new measurement techniques 
are developed. More to the point with respect to Medtronic's concerns 
herein, the Commission affirms that the new rules do not preclude use 
of the ``human torso'' simulator described in the former MICS rules. 
Finally, as with the transmitter power measurement issue, the 
Commission notes that the OET Laboratory Division has published 
information in its KDB concerning acceptable measurement procedures 
under this provision, including a statement that use of the human torso 
technique formerly codified in the MICS rules continues to be 
acceptable.

Paperwork Reduction Analysis

    20. This document does not contain new or modified information 
collection requirements subject to the Paperwork Reduction Act of 1995 
(PRA), Public Law 104-13. In addition, therefore, it does not contain 
any new or modified information collection burden for small business 
concerns with fewer than 25 employees, pursuant to the Small Business 
Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 
3506(c)(4).

Congressional Review Act

    21. The Commission will send a copy of this Memorandum Opinion and 
Order, in a report to be sent to Congress and the Government 
Accountability Office pursuant to the Congressional Review Act, see 5 
U.S.C. 801(a)(1)(A).

Final Regulatory Flexibility Analysis

    22. As required by the Regulatory Flexibility Act of 1980, as 
amended (RFA),\1\ an Initial Regulatory Flexibility Analysis (IRFA) was 
incorporated in the Notice of Proposed Rulemaking (MedRadio NPRM) in 
this proceeding.\2\ The Commission sought written public comment on the 
proposals in the MedRadio NPRM, including comment on the IRFA. In 
addition, a Final Regulatory Flexibility Analysis (FRFA) was 
incorporated in the subsequent Report and Order (MedRadio Order) in 
this same proceeding.\3\ This Final Regulatory Flexibility Analysis 
(FRFA) for the subject Memorandum Opinion and Order conforms to the 
RFA.\4\
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    \1\ See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601-612, has been 
amended by the Small Business Regulatory Enforcement Fairness Act of 
1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 857 (1996).
    \2\ See Investigation of the Spectrum Requirements for Advanced 
Medical Technologies, Amendment of Parts 2 and 95 of the 
Commission's Rules to Establish the Medical Device Radio 
Communications Service at 401-402 and 405-406 MHz, Dexcom, Inc., 
Request for Waiver of the Frequency Monitoring Requirements of the 
Medical Implant Communications Service Rules, Biotronik, Inc. 
Request for Waiver of the Frequency Monitoring Requirements for the 
Medical Implant Communications Service Rules, ET Docket No. 06-135, 
RM-11271, Notice of Proposed Rule Making and Notice of Inquiry and 
Order, (MedRadio NPRM) 21 FCC Rcd 8164 (2006).
    \3\ See Investigation of the Spectrum Requirements for Advanced 
Medical Technologies, Amendment of Parts 2 and 95 of the 
Commission's Rules to Establish the Medical Device Radio 
Communications Service at 401-402 and 405-406 MHz, Dexcom, Inc., 
Request for Waiver of the Frequency Monitoring Requirements of the 
Medical Implant Communications Service Rules, Biotronik, Inc. 
Request for Waiver of the Frequency Monitoring Requirements for the 
Medical Implant Communications Service Rules, ET Docket No. 06-135, 
RM-11271, Report and Order, (MedRadio Report and Order) 24 FCC Rcd 
22696 (2009).
    \4\ See 5 U.S.C. 604.
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A. Need for and Objective of Adopted Rules

    23. The subject Memorandum Opinion and Order responds to the 
Petition for Reconsideration submitted by Medtronic, Inc. on June 15, 
2009.\5\ It grants reconsideration to the extent of including a 
provision in the MedRadio rules that permits the submission of 
transmitter output power measurements made using average power 
instrumentation techniques. It also makes several minor corrections or 
clarifications of an editorial nature with respect to other provisions. 
It denies reconsideration in all other respects.
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    \5\ See Petition for Reconsideration, ET Docket No. 06-135, 
filed by Medtronic on June 15, 2009.
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    24. The need for and objectives of the amended rules adopted in 
this Memorandum Opinion and Order are the same as those discussed in 
the FRFA for the Report and MedRadio Order. In the MedRadio Order, the 
Commission found that additional spectrum was required for the 
operation of advanced medical devices using wireless telecommunication 
technologies. Thus, building upon the legacy Medical Implant 
Communications Service (MICS), the Commission adopted service and 
technical rules for a new MedRadio Service that replicated, and 
expanded upon, many of the former MICS requirements. For example, the 
legacy MICS rules limited operation to implanted medical devices. 
However, the rules for the new MedRadio Service adopted in the MedRadio 
Order accommodate body-worn as well as implanted medical devices. Under 
this framework, the rules for MedRadio service incorporates the MICS 
``core'' band at 402-405 MHz--which continues to be limited to 
implanted devices; and also includes two megahertz of newly designated 
spectrum in the adjacent ``wing'' bands at 401-402 MHz and 405-406 
MHz-- in which both body-worn and implanted devices are permitted. As 
with the MICS, the MedRadio service is housed within Part 95 of the 
Commission's rules.\6\ As a result, the legacy MICS and new MedRadio 
rules share many of the same licensing and technical requirements. 
Altogether, the MedRadio service provides a total of five megahertz of 
contiguous spectrum for advanced wireless medical radiocommunication 
devices serving a

[[Page 52476]]

diverse range of diagnostic and therapeutic purposes in humans.
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    \6\ Part 95 governs the Personal Radio Services, including 
General Mobile Radio Service, Radio Control Service and Citizens 
Band (CB) Radio Service. The CB Radio Service, in turn, covers a 
number of specialized services, including the MedRadio Service. As 
with the legacy MICS, the MedRadio service devices operate on a 
secondary, non-interference basis with respect to primary authorized 
services and, as such, they must accept harmful interference from 
devices operated under such services. Further, MedRadio devices 
operate on a shared, non-exclusive basis with respect to each other 
and other secondary devices.
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B. Summary of Significant Issues Raised by Public Comments in Response 
to the FRFA

    25. No comments were filed in response to the FRFA in this 
proceeding. In addition, no comments were submitted concerning small 
business issues.

C. Description and Estimate of the Number of Small Entities to Which 
the Adopted Rules Will Apply

    26. The RFA directs agencies to provide a description of and, where 
feasible, an estimate of the number of small entities that may be 
affected by the proposed rules, if adopted.\7\ The RFA generally 
defines the term ``small entity'' as having the same meaning as the 
terms ``small business,'' ``small organization,'' and ``small 
governmental jurisdiction.'' \8\ In addition, the term ``small 
business'' has the same meaning as the term ``small business concern'' 
under the Small Business Act.\9\ A small business concern is one which: 
(1) Is independently owned and operated; (2) is not dominant in its 
field of operation; and (3) satisfies any additional criteria 
established by the SBA.\10\
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    \7\ 5 U.S.C. 603(b)(3).
    \8\ 5 U.S.C. 601(6).
    \9\ 5 U.S.C. 601(3) (incorporating by reference the definition 
of ``small business concern'' in 15 U.S.C. 632). Pursuant to the 
RFA, the statutory definition of a small business applies ``unless 
an agency, after consultation with the Office of Advocacy of the 
Small Business Administration and after opportunity for public 
comment, establishes one or more definitions of such term which are 
appropriate to the activities of the agency and publishes such 
definition(s) in the Federal Register.'' 5 U.S.C. 601(3).
    \10\ Small Business Act, 15 U.S.C. 632 (1996).
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    27. In the FRFA the Commission stated that nationwide, there are a 
total of approximately 22.4 million small businesses, according to SBA 
data.\11\ A ``small organization'' is generally ``any not-for-profit 
enterprise which is independently owned and operated and is not 
dominant in its field.'' \12\ Nationwide, as of 2002, there were 
approximately 1.6 million small organizations.\13\ The term ``small 
governmental jurisdiction'' is defined generally as ``governments of 
cities, towns, townships, villages, school districts, or special 
districts, with a population of less than fifty thousand.'' \14\ Census 
Bureau data for 2002 indicate that there were 87,525 local governmental 
jurisdictions in the United States.\15\ The Commission estimates that, 
of this total, 84,377 entities were ``small governmental 
jurisdictions.'' \16\ Thus, we estimate that most governmental 
jurisdictions are small.
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    \11\ See SBA, Programs and Services, SBA Pamphlet No. CO-0028, 
at page 40 (July 2002).
    \12\ 5 U.S.C. 601(4).
    \13\ Independent Sector, The New Nonprofit Almanac & Desk 
Reference (2002).
    \14\ 5 U.S.C. 601(5).
    \15\ U.S. Census Bureau, Statistical Abstract of the United 
States: 2006, Section 8, page 272, Table 415.
    \16\ We assume that the villages, school districts, and special 
districts are small, and total 48,558. See U.S. Census Bureau, 
Statistical Abstract of the United States: 2006, section 8, page 
273, Table 417. For 2002, Census Bureau data indicate that the total 
number of county, municipal, and township governments nationwide was 
38,967, of which 35,819 were small. Id.
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    28. Radio and Television Broadcasting and Wireless Communications 
Equipment Manufacturing. The Census Bureau defines this category as 
follows: ``This industry comprises establishments primarily engaged in 
manufacturing radio and television broadcast and wireless 
communications equipment. Examples of products made by these 
establishments are: transmitting and receiving antennas, cable 
television equipment, GPS equipment, pagers, cellular phones, mobile 
communications equipment, and radio and television studio and 
broadcasting equipment.'' \17\ The SBA has developed a small business 
size standard for firms in this category, which is: all such firms 
having 750 or fewer employees.\18\ According to Census Bureau data for 
2002, there were a total of 1,041 establishments in this category that 
operated for the entire year.\19\ Of this total, 1,010 had employment 
of under 500, and an additional 13 had employment of 500 to 999.\20\ 
Thus, under this size standard, the majority of firms can be considered 
small.
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    \17\ U.S. Census Bureau, 2007 NAICS Definitions, ``334220 Radio 
and Television Broadcasting and Wireless Communications Equipment 
Manufacturing''; https://www.census.gov/naics/2007/def/ND334220.HTM#N334220.
    \18\ 13 CFR 121.201, NAICS code 334220.
    \19\ U.S. Census Bureau, American FactFinder, 2002 Economic 
Census, Industry Series, Industry Statistics by Employment Size, 
NAICS code 334220 (released May 26, 2005); https://factfinder.census.gov. The number of ``establishments'' is a less 
helpful indicator of small business prevalence in this context than 
would be the number of ``firms'' or ``companies,'' because the 
latter take into account the concept of common ownership or control. 
Any single physical location for an entity is an establishment, even 
though that location may be owned by a different establishment. 
Thus, the numbers given may reflect inflated numbers of businesses 
in this category, including the numbers of small businesses. In this 
category, the Census breaks out data for firms or companies only to 
give the total number of such entities for 2002, which was 929.
    \20\ Id. An additional 18 establishments had employment of 1,000 
or more.
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D. Description of Reporting, Recordkeeping, and Other Compliance 
Requirements for Small Entities

    29. The Memorandum Opinion and Order does not change any of the 
reporting, recordkeeping, or other compliance requirements resulting 
from the rules adopted in the MedRadio Order. As stated above, the only 
substantive rule change in the Memorandum Opinion and Order merely 
reinstates a provision from the former MICS rules that permits the 
submission of average power transmitter measurements.
    30. Furthermore, as stated in the FRFA, the rules adopted by the 
Commission in the MedRadio Order use the same licensing approach for 
the entire 401-406 MHz MedRadio band that was previously used for the 
legacy MICS band at 402-405 MHz. Rather than require individual 
transmitter licensing, the Commission authorizes operation by rule 
within the Citizens Band (CB) Radio Service under Part 95 of our Rules 
and pursuant to Section 307(e) of the Communications Act.\21\ Thus, 
licensing will be accomplished through adherence to applicable 
technical standards and other operating rules. The Commission concluded 
in the MedRadio Order that this approach is beneficial because it would 
minimize the administrative burden on prospective licensees as compared 
with an individual licensing scheme.
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    \21\ We note that 47 U.S.C. 307(e)(3) provides that the term 
``citizens band radio service'' shall have the meaning given it by 
the Commission by rule. 47 U.S.C. 307(e)(1) provides that upon 
determination by the Commission that an authorization serves the 
public interest, convenience, and necessity, the Commission may by 
rule authorize the operation of radio stations without individual 
licenses in the citizens band radio service.
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E. Steps Taken To Minimize Significant Economic Impact on Small 
Entities, and Significant Alternatives Considered

    31. The RFA requires an agency to describe any significant 
alternatives that it has considered in reaching its proposed approach, 
which may include the following four alternatives (among others): (1) 
The establishment of differing compliance or reporting requirements or 
timetables that take into account the resources available to small 
entities; (2) the clarification, consolidation, or simplification of 
compliance or reporting requirements under the rule for small entities; 
(3) the use of performance, rather than design, standards; and (4) an 
exemption from coverage of the rule, or any part thereof, for small 
entities.\22\
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    \22\ See 5 U.S.C. 603(c).

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[[Page 52477]]

    32. In the preceding MedRadio NPRM, the Commission sought comment 
on which regulatory approaches would be appropriate to govern the 
MedRadio Service. Subsequently, in the MedRadio Order the Commission 
considered the responsive comments filed by interested parties, and 
determined that record as a whole supported extending the license-by-
rule approach under Part 95--used by the former MICS--to the new 
MedRadio service because of the reduced regulatory impact on all 
licensees.

F. Report to Congress

    33. The Commission will send a copy of the Memorandum Opinion and 
Order, including this FRFA, in a report to be sent to Congress pursuant 
to the Congressional Review Act.\23\ In addition, the Commission's 
Consumer and Governmental Affairs Bureau will send a copy of the 
Memorandum Opinion and Order, including the FRFA, to the Chief Counsel 
for Advocacy of the SBA.
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    \23\ See 5 U.S.C. 801(a)(1)(A).
---------------------------------------------------------------------------

Ordering Clauses

    34. Pursuant to the authority contained in Sec. Sec.  4(i), 302, 
303(e), 303(f), and 307 of the Communications Act of 1934, as amended, 
47 U.S.C. 154(i), 302, 303(c), 303(f), and 307 this Memorandum Opinion 
and Order is hereby adopted.
    35. Part 95 of the Commission's rules is amended and such rule 
amendments shall be effective September 27, 2010
    36. Pursuant to Sec. Sec.  4(i), 302, 303(e) 303(f), 303(g), 303(r) 
and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 
154(i), 302, 303(e), 303(f), 303(g) and 405, that the petition for 
reconsideration filed by Medtronic, Inc. Is granted in part and denied 
in part as set forth.
    37. The Commission's Consumer and Governmental Affairs Bureau, 
Reference Information Center, shall send a copy of this Memorandum 
Opinion and Order, including the Final Regulatory Flexibility Analysis, 
to the Chief Counsel for Advocacy of the Small Business Administration.
    38. It is further ordered that ET Docket No. 06-135 is terminated.

List of Subjects in 47 CFR Part 95

    Communications equipment, Medical devices.

Federal Communications Commission.
Marlene H. Dortch,
Secretary.

Final Rules

0
For the reasons discussed in the preamble, the Federal Communications 
Commission amends 47 CFR part 95 to read as follows:

PART 95--PERSONAL RADIO SERVICES

0
1. The authority citation for part 95 continues to read as follows:

    Authority: Sections 4, 303, 48 Stat. 1066, 1082, as amended; 47 
U.S.C. 154, 303.

0
2. Section 95.628 is amended by revising paragraphs (a)(4), (b)(2) 
through (b)(4), and (g)(3) introductory text to read as follows:


Sec.  95.628  MedRadio transmitters.

    (a) * * *
    (4) If no signal in a MedRadio channel above the monitoring 
threshold power level is detected, the MedRadio programmer/control 
transmitter may initiate a MedRadio-communications session involving 
transmissions to and from a medical implant or medical body-worn device 
on that channel. The MedRadio communications session may continue as 
long as any silent period between consecutive data transmission bursts 
does not exceed 5 seconds. If a channel meeting the criteria in 
paragraph (a)(3) of this section is unavailable, MedRadio transmitters 
that are capable of operating on multiple channels may transmit on the 
alternate channel accessible by the device with the lowest monitored 
ambient power level. Except as provided in paragraph (b) of this 
section, MedRadio transmitters that operate on a single channel and 
thus do not have the capability of operating on alternate channels may 
not transmit unless no signal on the single channel of operation 
exceeds the monitoring threshold power level.
* * * * *
    (b) * * *
    (2) MedRadio devices operating in either the 401-401.85 MHz or 405-
406 MHz bands, provided that the transmit power is not greater than 250 
nanowatts EIRP and the duty cycle for such transmissions does not 
exceed 0.1%, based on the total transmission time during a one-hour 
interval, and a maximum of 100 transmissions per hour.
    (3) MedRadio devices operating in the 401.85-402 MHz band, provided 
that the transmit power is not greater than 25 microwatts EIRP and the 
duty cycle for such transmissions does not exceed 0.1%, based on the 
total transmission time during a one hour interval, and a maximum of 
100 transmissions per hour.
    (4) MedRadio devices operating with a total emission bandwidth not 
exceeding 300 kHz centered at 403.65 MHz, provided that the transmit 
power is not greater than 100 nanowatts EIRP and the duty cycle for 
such transmissions does not exceed 0.01%, based on the total 
transmission time during a one-hour interval, and a maximum of 10 
transmissions per hour.
* * * * *
    (g) * * *
    (3) Radiated emissions and EIRP measurements may be determined by 
measuring the radiated field from the equipment under test at 3 meters 
and calculating the EIRP. The equivalent radiated field strength at 3 
meters for 25 microwatts, 250 nanowatts, and 100 nanowatts EIRP is 
18.2, 1.8, or 1.2 mV/meter, respectively, when measured on an open area 
test site; or 9.1, 0.9, or 0.6 mV/meter, respectively, when measured on 
a test site equivalent to free space such as a fully anechoic test 
chamber. Compliance with the maximum transmitter power requirements set 
forth in Sec.  95.639(f) shall be based on measurements using a peak 
detector function and measured over an interval of time when 
transmission is continuous and at its maximum power level. In lieu of 
using a peak detector function, measurement procedures that have been 
found to be acceptable to the Commission in accordance with Sec.  2.947 
of this chapter may be used to demonstrate compliance.
* * * * *

0
3. Section 95.1209 is amended by revising paragraph (d) to read as 
follows:


Sec.  95.1209  Permissible communications.

* * * * *
    (d) For the purpose of facilitating MedRadio system operation 
during a MedRadio communications session, as defined in Sec.  95.628, 
MedRadio transmitters may transmit in accordance with the provisions of 
Sec.  95.628(a) for no more than 5 seconds without the communications 
of data; MedRadio transmitters may transmit in accordance with the 
provisions of Sec.  95.628(b)(2) and (b)(3) for no more than 3.6 
seconds in total within a one hour time period; and MedRadio 
transmitters may transmit in accordance with the provisions of Sec.  
95.628(b)(4) for no more than 360

[[Page 52478]]

milliseconds in total within a one hour time period.
* * * * *

 [FR Doc. 2010-21011 Filed 8-25-10; 8:45 am]
BILLING CODE 6712-01-P